Increasing life expectancy has created large dynamic, active and vocal population subset in the United States consisting of people over the age of 40. Coupled with the major movement of women into the workplace and highly marketed youth oriented lifestyle ideals, there is an increasing national preoccupation with the field of anti-aging in general, and maintaining a fit and youthful facial appearance in particular.
The magnitude of this phenomenon can be inferred from the fact that Americans spend over $28 Billion a year on anti-aging face creams (most of which are ineffective), and last year 12.4 million Plastic Surgery operations were performed, over half of which were done to “rejuvenate the face.
In spite of this major effort and expenditure, few if any facial rejuvenation procedures effectively reverse the signs of facial aging and restore an aging face to a truly youthful appearance. The reasons are many and reflect a “one size fits all” approach to the field of facial aging and it's rejuvenation by the cosmetic, pharmaceutical, medical, and plastic surgery industries. Additionally, the fact that the most effective current facial rejuvenation methods require surgery dissuades many from pursuing facial rejuvenation for fear of having surgery. The immense demand for non-surgical facial rejuvenation and the lack of effective non-surgical facial rejuvenation techniques have led to a plethora of heavily marketed ineffective one size fits all facial rejuvenation schemes from wrinkle creams to, in one case, an incredible $10,000.00 week end “face lift in Manahatten which consists primarily of eating salmon and taking vitamins.
A major problem of the rejuvenation methods of the prior art is that most if not all current facial rejuvenation methods are uni-modal and as such fail to address the fact that facial aging changes are multifaceted and a combination of many physiological, histological, and structural changes that occur over a lifetime. The attempt to correct facial aging with one modality which can correct only one or a few components of the facial aging process will only achieve a partial correction or no correction at all.
To better understand the requirements for a truly effective facial rejuvenation technique one must understand the basic components of the facial aging changes that produce an aged appearance to the face, which may be illustrated by a visual comparison of a young face, such as that of an infant or child, and an old face, such as that of a person in their forties or older.
While it is apparent that the appearance of the child's facial skin is strikingly different from that of an older adult, it is helpful to objectively define the significant age related changes of the adult man's skin that are in fact due to aging as opposed to those changes that are related to the growth and development of the person, that is, the maturation process by which a person develops from childhood to adulthood. A realization and understanding of the “aging processes” and effects separate and apart from the maturation processes will assist in understanding what structural elements or aspects of a persons face have to be altered, or “rejuvenated”, and in what manner, to restore a youthful appearance to an older person's face.
Many of the age related facial changes that need to be modified for effective facial rejuvenation are illustrated in FIG. 1 shows an illustrative aged face 10A on the left side of the image and, for comparison, a illustrative youthful face 10B on the right side of the image. As illustrated therein, the facial changes and effects resulting from aging, as opposed to maturation, may include, for example, frown lines 12A, “bunny” lines 12B, “worry” lines 12C, brow ptosis 12D, eyelid laxity 12E, “crow's feet” 12F, eyelid bags 12G, tear through deformities 12H, nasal labial folds 12I, “marionette” lines 12J, platysmal bands 12K and “lipstick” lines 12L.
Facial skin aging changes such as those illustrated in FIG. 1 may be generally categorized into Type 1 and Type 2 facial aging changes. Type 1 aging changes are superficial and may be observed as changes in the superficial layer of the skin called the Epidermis. Type 1 aging changes may be illustrated by comparison of a child's face with an older adult's face wherein it will be apparent that the child's skin appears smooth, moist, free of blemishes, spots and wrinkles. By contrast, the older adults skin appears rough, dry, and sallow, with multiple brown spots, red spots, and wrinkles. The causes of these visible superficial changes are multi-factorial and include heredity, exposure to UV light from the sun and toxins, and molecular aging events involving DNA in the body's cells. The surface cells of the skin are histologically abnormal, which gives a dry dull cast to the skin, and multiple brown pigment and red blood vessel spots create a non-uniform blemished appearance to the skin and wrinkles are a pathognomonic sign of facial aging that everyone recognizes.
Type 2 facial aging changes are the result of changes in the deeper portion of the skin called the Dermis wherein aging results in severe damage to the dermis primarily as destruction and loss of collagen and elastin, which are major supportive elements of the dermis that provide elasticity, firmness, and fullness to the facial skin. Aging also results in atrophy of the subcutaneous (beneath the skin) fat, which results in looseness of the skin and thinning of the skin. The effect of these changes is seen in the aged face 10A of FIG. 1 where the aged skin can be seen sagging and falling into folds over the face.
Another type2 facial aging change is caused by the action of the muscles of facial expression that pull on the skin as they express our emotions. Over a lifetime the repeated action of these muscles produces the lines of facial expression, frown lines, crow's feet, worry lines and bunny lines, all of which, when they become permanent, provide a classic, easily recognizable appearance of facial age.
The final component of facial aging that contributes to an aged facial appearance is slow, gradual bone atrophy, which contributes minimally but further to the facial sagging and downward descent of the facial skin as the underlying structural support of the bone is gradually lessened.
Therefore considering the current state of the art of facial rejuvenation therapies, the “gold standard” of facial rejuvenation therapy has for many years been the plastic surgical procedures known as the face-lift, or rhytidectomy, and the eyelid rejuvenation procedure known as the blepharoplasty. As is well known in the relevant arts, these surgical procedures remove a portion of the damaged aged skin through incisions around the ear and on the eyelids and, when the incisions are closed, the remaining aged skin is pulled tighter as the result of the loose skin being removed. While the facial and eyelid contours are improved, the remaining skin on the face is still aged and displays both Type 1 and Type 2 facial aging changes, so that while the patients are left with a tighter face, the facial skin is still aged in appearance, which is hardly an effective facial rejuvenation. Fears of surgery and the possibility of serious complications such as facial paralysis have also limited the acceptance and thus application of these surgical techniques.
Another rejuvenation method of the prior art is facial resurfacing operations, such as chemical peel and laser resurfacing procedures, have also been used and which do effectively remove wrinkles and provide some skin tightening. Effective facial rejuvenation, however, requires a deep “peel” which results in loss of skin pigment which in turn creates an unsightly demarcation line below the jaw where old skin stands out on the neck when compared to the resurfaced skin on the face. Complications such as scarring are also very common. Because of these complications, such procedures have not gained wide acceptance by physicians and patients.
In the early 1980's yet another rejuvenation method that involved injectable collagen was introduced wherein the collagen serves as a soft tissue filler that is injected into the face beneath wrinkles, scars, and deep facial lines to plump or fill out these aging associated facial depressions. While initial results were encouraging, the soft fillers “plumped up” lines and wrinkles, but did not correct Type 1 surface changes and did not address the facial laxity associated with aging. The use of injected collagen or other soft tissue fillers was further limited by the fact that the effect of such injections lasted only 6 weeks to 3 months because of degradation of the filler within the body, and by the fact that many people were allergic to the soft tissue fillers.
In the past three years improved soft tissue fillers have been introduced using, for example, hyaluronic acid, polymethyl methacrylate, calcium hydroxy apatite, polyglycolic acid, bioengineered human skin type 1 collagen, cultured fibroblasts, morselized cadaver tendon and collagen, and autogenous fat and dermis. All of these agents have beneficial initial effects but all are temporary as their effect lasts at most a year. More importantly, however, is the fact that soft tissue filler injections are uni-modal and address only one aspect of facial skin aging, that is, the loss of volume secondary to atrophy of subcutaneous fat and dermis.
In the mid 1990's a new high tech revolution in the field of facial rejuvenation began with the introduction of the laser as a new facial rejuvenation tool. In 1995 the CO2 laser was introduced as a facial resurfacing tool, followed several years later by the Erbium laser, which was a significant improvement over the CO2 laser because the Erbium laser produced less heat and thus less injury to the facial skin and thus fewer complications. Radiofrequency energy was also used for this purpose.
These technologies have not gained wide acceptance, however, because they are ablative procedures, which means that the skin is ablated or surgically removed, necessitating a prolonged period of surgical recovery or “down time”, with have associated complications, such as hypopigmentation (loss of skin color), scarring, and demarcation lines. In addition, they remain uni-modal and do not address all of the Type 2 facial aging changes, such as the lines of facial expression and subcutaneous fat atrophy.
Since 2000 a new class of non-ablative technologies have been introduced to rejuvinate the facial skin without the limitations imposed by the surgical recovery times and complications of the ablative laser procedures. These new non-ablative procedures utilize laser, intense pulsed light, radiofrequency, and infrared energies to injure the deep layers of the skin, that is, the dermis, to stimulate a healing response, that is, a controlled scar, which results in the formation of new collagen to replace the damaged aged collagen previously present in the skin. The theory is that if new collagen can be produced to replace the aged damaged collagen, skin texture and elasticity will be restored, the skin will be plumped and wrinkles will be removed. As a practical matter, the best results achieved by the most successful technologies show at best a 20% reduction of fine facial wrinkles only after 5-7 treatments over a period of 7 months. Again these technologies are uni-modal in that they leave type1 superficial changes unaltered and thus at best achieve only a partial facial rejuvenation effect, and have associated undesired side effects such as discussed above.
A group of related procedures have been used concurrently with the above discussed “non-ablative” methods to remove Type1 facial aging changes, such pigment (brown spots) and vessels (red spots) through a process called selective photothermolysis, that is, light destruction of cells by selective heating. These technologies have been remarkably successful in correcting pigmentary (brown spot) and vascular (blood vessel) Type 1 facial aging changes, but do not address neither the textural type 1 changes nor the Type 2 deeper facial aging changes. A new (2005) laser modality, referred to as the Fraxel® laser, does address pigment and texture problems and possibly promotes new collagen production, but does not remove vessels and does not tighten the skin, so that this method again addresses only a portion of the effects that must be addressed to achieve satisfactory skin rejuvenation. skin Again, all of these technologies deliver significant thermal energy to the skin and must be accompanied by sophisticated cooling devices to avoid burn injury to the skin, and the risk of skin injury by inappropriate or incorrect use remains a significant risk to the patient in terms of scarring.
In the past three years (2002-2005), radiofrequency and infrared energy have been utilized to deliver heating to the deeper dermis layer of the skin in an attempt to modify or remodel the collagen in the dermis to a shorter more compact configuration in an attempt to tighten the skin. The best clinical studies to date have demonstrated at best a 30% tightening of the skin in 30% of patients treated, most commonly only patients with thinner skin and little subcutaneous fat. Furthermore, the risk of thermal injury to the skin is present, requiring sophisticated skin cooling devices during treatment. Effective results also require expert application of the technique, a time consuming fastidious process, and repeated (3-5) treatments over a period of 5-7 months. In the most successful cases, however, the Type 1 facial aging changes are not addressed, leaving tightened but old looking skin on the surface, again a result of a uni-modal approach to a multi-faceted problem.
It will be noted that none of the above discussed therapies address Type 2 facial aging changes caused, for example, by the contraction of the muscles of facial expression, the crow's feet, worry lines, frown lines, and bunny lines, which are the general hallmarks of an aged facial appearance. In the past two years, the use of a muscle-
paralyzing agent, such as Botox®, has been effectively used to relax the muscles of facial expression and remove the lines associated with musclecontraction. Botox®, which was FDA approved in 2004, has gained wide popularity as a useful agent in facial rejuvenation for reducing or eliminating the lines of facial expression. Its usefulness is limited, however, by the fact that its effect is temporary, lasting only 6 months to one year. In addition, and like the other methods discussed above, Botox® is uni-modal therapy having no effect on Type 1 facial aging changes and only addressing one of several Type 2 facial aging changes.
The net result after nearly a half -century of research and development and the expenditure of many millions of dollars is that the goal of rejuvenating an aged facial appearance remains an elusive yet much sought after goal. While an aging face does not threaten the life of the individual, the contribution to quality of life for a significant and likely increasing highly motivated segment of the population is significant, as demonstrated by the enormous financial expenditures both by patients and commercial research endeavors in this field.
The present invention provides a solution to these and related problems of the prior art.